Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2023-09-28

Brief Summary

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The worldwide prevalence of chronic constipation (CC) is 15%, and women are more likely to develop the disease than men. CC have a significant impact on quality of life and increase the burden of national health insurance. The conventional medication treatments are primarily symptom-specific and have limited efficacy. Previous small sample study had shown the therapeutic potential of transcutaneous auricular vagus nerve stimulation (taVNS) for irritable bowel syndrome with constipation (IBS-C). The aim of this study was to investigate whether taVNS could improve defecation condition and constipation symptoms in patients with CC.

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Detailed Description

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Conditions

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Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group

patients will receive taVNS at left tragus for four weeks.

Group Type EXPERIMENTAL

taVNS

Intervention Type DEVICE

Patients will receive taVNS (device produced by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; amplitude of 0-2 mA at the maximum level that the patient could tolerate; pulse width: 0.5ms)

Laxative Agent

Intervention Type DRUG

Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.

Sham-treatment group

patients will receive sham-taVNS at left earlobe for four weeks.

Group Type SHAM_COMPARATOR

taVNS

Intervention Type DEVICE

Patients will receive taVNS (device produced by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; amplitude of 0-2 mA at the maximum level that the patient could tolerate; pulse width: 0.5ms)

Laxative Agent

Intervention Type DRUG

Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.

Interventions

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taVNS

Patients will receive taVNS (device produced by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; amplitude of 0-2 mA at the maximum level that the patient could tolerate; pulse width: 0.5ms)

Intervention Type DEVICE

Laxative Agent

Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. FC or IBS-C patients aged 18-75 years who meet the diagnostic criteria for Rome IV;
2. Complete spontaneous bowel movements (CSBMs) per week \< 3;
3. No constipation medication used for at least 2 weeks prior to enrollment, not participated in clinical trials in the past three months, and no abnormal colonoscopy within the past 12 months in those with alarm symptoms.

Exclusion Criteria

1. Have cognitive impairment, psychiatric disorders, or conditions that may affect patient cooperation;
2. Have a cardiac pacemaker implantation or other electronically implanted devices;
3. Prior taVNS treatment;
4. History of colorectal surgery, except for simple appendectomy;
5. Severe cardiovascular, hepatic, or renal disease;
6. Known malignancy;
7. Secondary constipation caused by medications and other diseases;
8. Pregnant or lactating women;
9. Refusal to sign an informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No